A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer

Trial Information

A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer

OBJECTIVES:

- Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.

- Determine the tolerability and toxicity of this regimen in these patients.

OUTLINE: Patients are stratified according to number of prior chemotherapy courses for metastatic disease (0 vs 1).

Patients receive etoposide IV over 60-90 minutes, cisplatin IV over 30 minutes, and ifosfamide IV over 30 minutes on days 1-3. Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months.

PROJECTED ACCRUAL: At least 36 patients (16 per stratum) will be accrued over 36 months.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically proven progressive metastatic breast cancer

- Measurable disease

- Any lesion measurable in 2 dimensions

- Hepatic metastases if the sum of the measurements below the costal margin in the midclavicular line and the tip to the xiphoid process is greater than 5 cm during quiet respiration

- Hepatic defects that are clearly measurable by radionuclide, CAT, or MRI scans

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